Operations Continuous Improvement Associate PPP NA, Gx BER, Ohio
$24.35/hr
Main tasks
- The Operations Continuous Improvement (CI) Associate supports daily manufacturing operations while driving process improvements, reducing waste, and enhancing efficiency, quality, and safety in a GMP-regulated pharmaceutical packaging environment, contributing to improved SQDC performance and overall equipment effectiveness (OEE) in primary plastic packaging production.
Area of responsibility
- Overall responsible for all activities within PPP NA (Gx Berlin, Ohio)
Operational Support:
- Work directly on the production floor to support manufacturing teams in maintaining stable, efficient operations.
- Monitor production processes to identify real-time inefficiencies, defects, downtime causes, and performance gaps.
- Assist operators and supervisors in troubleshooting process and equipment issues.
- Ensure adherence to standard work, batch records, and Good Manufacturing Practices (GMP) procedures.
- Follow all safety policies and procedures, including proper use of required PPE.
- Safely perform physical tasks, including lifting up to 56 lbs and moving up to 200 lbs with appropriate assistance or equipment.
Continuous Improvement Execution:
- Support Lean Manufacturing initiatives including 6S, Kaizen events, SMED, and standardized work implementation.
- Identify and eliminate waste (motion, waiting time, scrap, overproduction, and rework).
- Collect, analyze, and interpret production data to identify trends, losses, and improvement opportunities.
- Participate in daily tier meetings and Gemba walks to support performance tracking and improvement actions.
- Assist in implementing corrective and preventive actions (CAPA) related to operational issues.
Process Optimization:
- Support improvement projects aimed at increasing OEE and overall line efficiency.
- Assist with trial runs, process adjustments, and validation of operational improvements.
- Collaborate with Maintenance to improve equipment reliability and reduce unplanned downtime.
- Analyze production performance data (scrap rates, cycle times, downtime, yield loss) to support improvement efforts.
Quality & GMP Compliance:
- Ensure all activities comply with FDA regulations (21 CFR Part 210/211) and internal quality systems.
- Support investigations of deviations, non-conformances, and production quality issues.
- Maintain strict adherence to cleanroom and contamination control requirements where applicable.
- Assist with documentation updates, change control processes, and operational audit readiness.
- Participate in 6S and operational audits and support continuous improvement initiatives.
Cross-Functional Collaboration:
- Work closely with Production, Quality Assurance, Technical, Engineering, and Supply Chain teams.
- Provide feedback from the production floor to support engineering and CI initiatives.
- Assist in training operators on new or improved processes and standard work procedures.
- Perform additional duties as required to support changing business needs.
Qualifications
- High school diploma or GED required, Associate degree in Manufacturing, Engineering Technology, Industrial Technology, or related field preferred
- 1–3 years of experience in a manufacturing environment
- Basic understanding of GMP (Good Manufacturing Practices) and regulated production environments
- Familiarity with Lean Manufacturing principles such as 6S, Kaizen, waste reduction, and standardized work
- Understanding of production performance metrics (OEE, scrap, downtime, yield) preferred
- Exposure to continuous improvement or structured problem-solving methodologies preferred
- Ability to read and interpret SOPs, batch records, and technical/controlled documentation
- Strong analytical, problem-solving, and attention-to-detail skills
- Proficiency in Microsoft Office applications (Excel, Word, PowerPoint)
- Strong communication and teamwork skills in a production environment
- Ability to work in a fast-paced, regulated manufacturing setting with strict adherence to safety and quality standards
- Strong organizational skills and ability to maintain accuracy in documentation and tasks
- Ability to speak, read, and write English
- Ability to obtain and maintain a mobile equipment license
